ES2539933T3 - Apparatus for applying material for the treatment of wounds using needles that penetrate the tissues - Google Patents

Abstract

A surgical apparatus (10), comprising: a first half section (11a) adapted to receive a disposable loading unit (20) at a distal end thereof; a second half-section (11b) in juxtaposed relation to the first half-section; a disposable loading unit (20) selectively operably coupled to the distal end of the first half section, the disposable loading unit including: a cartridge (22); a plurality of deployable needles (24) supported within the cartridge, wherein each needle includes a lumen extending therethrough and at least one hole (121) formed in an outer periphery thereof; a needle pusher (26) in operative association with each needle to deploy each needle from the cartridge and into a target tissue; and an actuator member (28) displaceable in translation within the cartridge to supply a driving force to each needle pusher to deploy the needles from the cartridge; and a wound treatment material applicator assembly for delivering wound treatment material to the target surgical site, the applicator assembly including: a first (4a) and a second (4b) reservoir supported on the distal end of a first and second respective semi-section; and a source of wound treatment material (6) in fluid communication with each reservoir.

Description

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DESCRIPTION

Apparatus for applying material for the treatment of wounds using needles that penetrate the tissues

BACKGROUND

Technical field

The present disclosure relates to surgical instruments and, more particularly, to a surgical apparatus capable of holding body tissue and applying a material for treating wounds to it.

Description of the related technique

Surgical procedures that require tissue cutting may result in bleeding in the area of the cut. Various techniques have been developed to successfully control bleeding, such as, for example, suturing, applying tweezers to blood vessels and using surgical fasteners, as well as electrocautery and other tissue heating techniques.

Surgical devices that use fasteners involve grasping or securing tissue between opposing mandibular structures and then joining the tissue using surgical fasteners. These devices are well known in the art. In some instruments, a blade is provided to cut the tissue that has been joined by the fasteners. Fixers are typically in the form of surgical clips, however, two-part polymeric fixators are also used.

The instruments for this purpose may comprise two elongate members that are used respectively to capture or hold tissue. Typically, one of the members carries a cartridge that houses a plurality of fasteners arranged in at least two lateral rows, while the other member comprises an anvil that defines a surface to form the legs of the fixer as the fasteners are driven from the cartridge. When two-part fasteners are used, the anvil carries the coupling part, for example the receiver, of the fasteners that are driven from the cartridge. Generally, the stapling operation is carried out by means of a pusher that moves longitudinally through the member carrying the cartridge, with the pusher acting on the clips to eject them sequentially from the cartridge. A blade can be moved with the pusher between the rows of staples to cut the stapled tissue between the rows of staples longitudinally (that is, form a cut line of the blade). Such instruments are disclosed in U.S. Patent Nos. 3,079,606 and 3,490,675.

A subsequent stapler disclosed in US Patent No. 3,499,591 provides a double row of staples on each side of the incision or the cutting line of the blade. This is achieved by providing a cartridge assembly in which a cam member moves through an elongated guide path between two sets of notches bearing stepped staples. Staple driving members are located within the notches and are positioned such that they are contacted by the longitudinally moving cam to expel the staples. Other examples of staplers are disclosed in U.S. Patent Nos. 4,429,695, 5,065,929 and 5,156,614. WO 2003/088845 A2 discloses a surgical stapling instrument comprising an anvil for staples and a staple cartridge. The staple cartridge includes one or more rows of laterally separated staple grooves, a plurality of surgical staples disposed within the grooves, and a biocompatible wound closure material, such as an adhesive, configured and adapted to increase the strength of the line of staples formed by firing the surgical clips through the layers of body tissue to mechanically fix the body tissue, and to activate and release the wound closure material in the body tissue to non-mechanically fix the adjacent layers of body tissue with each other.

In certain surgical procedures electrocautery devices are preferred to perform an improved hemostasis by heating tissue and blood vessels using thermogenic energy, preferably radiofrequency energy, to cause coagulation or cauterization. Monopolar devices use an electrode associated with a cutting or cautery instrument and a remote return electrode, usually attached externally to the patient. Bipolar instruments use two electrodes and the cauterization current is generally limited to tissue between the two electrodes of a tissue treatment part (eg, end effector) of an instrument.

Hemostatic electrosurgical stapling devices that combine the structural and functional aspects of stapling instruments and electrocautery devices generally provide enhanced hemostasis using thermogenic energy to cause coagulation or cauterization at or in the vicinity of the blade and fixation cutter line. Surgical to staple the tissue, before, during or after the use of thermogenic energy.

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Even though stapling, electrocautery or a combination of both techniques are generally very suitable for controlling bleeding along the cutting line of the blade, other techniques are intended to be used to control bleeding during surgical procedures.

Therefore, it is an aspect of the present disclosure to provide a surgical apparatus to provide hemostasis, joint or tissue welding that does not use conventional techniques.

SUMMARY

The present disclosure refers to a surgical device capable of attaching body tissue and applying a material for the treatment of wounds to it.

In accordance with one aspect of the present disclosure, a surgical apparatus is provided that includes a first half-section adapted to receive a disposable loading unit at a distal end thereof; a second half-section in juxtaposed relationship with the first half-section; a disposable loading unit selectively operatively coupled with the distal end of the first half section; and a material applicator set for wound treatment to deliver material for wound treatment to the target surgical site.

The disposable loading unit includes a cartridge; a plurality of deployable needles supported within the cartridge, in which each needle includes a light extending therethrough and at least one hole formed in an outer periphery thereof; a needle pusher in operative association with each needle to deploy each needle from the cartridge and into a target tissue; and an actuating member arranged so that it can travel in translation within the cartridge to provide a driving force to each needle pusher to deploy the needles from the cartridge.

The applicator assembly includes a first and second deposits supported on the distal end of a respective first and second half-section; and a source of material for the treatment of wounds in fluid communication with each deposit.

The source of wound treatment material may include at least one pressurized cylindrical receptacle of wound treatment material. Each cylindrical receptacle can be supported on one of the first and second half sections.

Each needle pusher includes an opening formed therein for fluid communication with the light of the respective needle.

The distal end of the first semi-section includes a plurality of openings provided between the reservoir and the cartridge resting on it to allow the transmission of wound treatment material from the reservoir to the cartridge. A plate that includes a plurality of needle receiving openings may be supported on the distal end of the second half section. Accordingly, a distal end of each needle may enter a respective needle receiving opening of the second half section during operation of the surgical apparatus.

An elastomeric material may be provided to confine the material for the treatment of wounds within the reservoir supported on the distal end of the second half section. Therefore, at the time of actuation of the surgical apparatus, a distal end of each needle penetrates the elastomeric material and the light of each needle is in fluid communication with the reservoir resting on the distal end of the second half section.

The material for the treatment of wounds is at least one of an adhesive, a sealant material, a hemostatic material and a medicament.

The disposable loading unit may include a requesting member operatively associated with at least one of the needles to request the needles to a retracted state. The surgical apparatus may also include a blade blade resting on the sliding drive platform to cut the tissue held between the distal ends of the first and second half sections. The blade can be moved along a longitudinal groove provided in the cartridge. It is provided that at least some needles are arranged on both sides of the longitudinal slot of the cartridge.

The applicator assembly may include a valve interposed fluidly between the source of wound treatment material and the reservoir.

In accordance with another aspect of the present disclosure, a method of operating on tissue in a target surgical area is provided. The method includes the step of providing a surgical apparatus. The surgical apparatus includes a disposable loading unit selectively operably supported at a distal end of a first half section, the disposable loading unit having a cartridge operatively supporting a

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plurality of deployable needles, in which each needle includes a light extending therethrough and at least one hole formed in an outer periphery thereof, and an actuating member arranged so that it can travel translationally within the cartridge for supply a driving force to each needle to deploy the needles from the cartridge. The surgical apparatus also includes an applicator set of material for

5 wound treatment to deliver material for the treatment of wounds to the target surgical zone. The applicator assembly includes at least one reservoir supported on a distal end of one of a first and second semi-section, and a source of wound treatment material in fluid communication with each reservoir;

The method further includes the steps of fastening adjacent layers of tissue between a distal end of a first and

10 a second semi-section of the surgical apparatus; activating the surgical apparatus, in which the activation of the surgical apparatus includes advancing the drive member distally to propel the plurality of needles through the subject tissue, and dispensing material for the treatment of wounds to the subject tissue from the source of material for the treatment of wounds, through the plurality of needles.

15 The source of wound treatment material may be pressurized. Therefore, at the time of activation of the surgical apparatus, the material for the treatment of wounds is expelled from the source thereof. Additionally, at the time of activation of the surgical apparatus, a distal end of each needle desirably enters a distal end of the second half section.

20 The surgical apparatus may include a reservoir resting on a distal end of each of the first and second semi-sections. Accordingly, the material for the treatment of wounds can be supplied in the light of each needle from each of the tanks.

The surgical apparatus may also include a movable knife blade so that it can move in translation

25 along the distal ends of the first and second half sections to cut tissue held between them, where at the time of activation of the surgical apparatus the blade blade is advanced distally along the distal ends of the first and second semi-sections to cut the tissue held between them.

BRIEF DESCRIPTION OF THE DRAWINGS

30 Hereinafter, various embodiments of the surgical apparatus will be described with reference to the drawings, in which:

Figure 1 is a perspective view of a surgical apparatus having an applicator of material for the

Wound treatment constructed in accordance with a preferred embodiment with the grip handle thereof disposed in an upright open position;

Figure 2 is a perspective view of the surgical apparatus illustrated in Figure 1 with the clamping handle arranged in a closed position;

Figure 3 is an exploded perspective view of the surgical apparatus of Figures 1 and 2;

Figure 4 is an exploded perspective view of the lower body part of the surgical apparatus of Figures 1 and 2;

Figure 5 is a cross-sectional view of the anvil components, as they would be seen along line 5-5 in Figure 3;

Figure 6 is a cross-sectional view of constructed cartridge components, and as they would be seen along line 6-6 in Figure 3;

Figure 7 is an enlarged perspective view and partial vertical cross-section with parts detached from a part of the adhesive applicator of the surgical apparatus of Figures 1 and 2;

Figure 8 is an enlarged side view with detached parts, showing the surgical apparatus of Figures 1 and 2 holding and applying adhesive to body tissue;

Figure 9 is an enlarged sectional view of a part of the wound treatment material applicator as would be seen along line 9-9 of Figure 8 showing the application of material for the wound.

60 wound treatment by the applicator of material for the treatment of wounds to adjacent body tissue;

Figure 10 is a schematic illustration of a distal end of a surgical apparatus that includes an applicator of wound treatment material constructed in accordance with an alternative embodiment of the present disclosure; Y

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Figure 11 is a schematic illustration of a distal end of a surgical apparatus that includes an applicator of wound treatment material constructed in accordance with another alternative embodiment of the present disclosure.

DETAILED DESCRIPTION OF EMBODIMENTS

The present disclosure provides a surgical apparatus that uses sealants, hemostatic materials and biological and / or synthetic adhesives (collectively referred to herein as wound treatment materials) to provide hemostasis, bonding or welding of the tissue. The use of wound treatment materials provides hemostasis and sealing in the short and long term, and / or reduces or prevents bleeding along a cutting line of the blade.

In the drawings and in the following description, the term "proximal", as is traditional, will refer to the end of the apparatus that is closest to the operator, while the term "distal" will refer to the end of the apparatus that is furthest from the operator.

Referring now to the drawings, in which similar reference numbers identify similar structural elements, a surgical apparatus 10 is illustrated in Figures 1 and 2, which has an applicator of wound treatment material constructed in accordance with a preferred embodiment. . The surgical apparatus 10 includes a cartridge or semi-section of needle release 11a (hereinafter referred to as the first half-section) and an anvil or semi-section for receiving needles 11b (hereinafter referred to as the second half-section). As will be readily apparent to those skilled in the art, the apparatus 10 is constructed in such a manner to substantially reduce the costs associated with its manufacture and assembly.

With reference to Figures 1-3, integral with the first half section 11a, the apparatus 10 includes a body part 12 defining a handle for gripping and supporting the device. A retaining channel 14 is mounted in the inner cavity 15 of the body part 12 adjacent to the distal end thereof. The retention channel 14 is sized and configured to support a disposable load unit 20.

As shown in Figures 4, 7 and 9, the disposable loading unit 20 includes a cartridge 22 having a plurality of slots 22a, 22b that retain a plurality of surgical needles 24. The disposable loading unit 20 further includes a plurality of needle pushers 26 adapted and configured to push or unfold the needles 24 out of or out through the slots 22a, 22b when driven by a driving force. Needle pushers 26 are also configured and sized to feed wound treatment material "W" into needles 24 through central openings 154 formed in pushers 26 (see Figure 9). The disposable loading unit 20 further includes an actuating member 28 (Figures 3, 4 and 8), shown in this case, for example, as a sliding platform, mounted to move through the cartridge 22 in a longitudinal direction to transmit a driving force to pushers 26 to apply or dispense wound treatment material "W" to an area of surgical application from or through holes 121 in the periphery of needles 24 (see Figure 9). Although the drive member 28 is shown as a sliding platform, it is provided and within the scope of the present disclosure that the drive member 28 may be cam rollers, cam slides and the like, as will be described in more detail below. with reference to figure 10.

Referring again to Figures 1-3, the wound treatment material "W", or a component thereof, is supplied to the surgical application area by means of an applicator assembly 2. The applicator assembly 2 includes a pair of tanks 4a, 4b in fluid communication with respective distal ends of first and second half sections 11a, and 11b. The reservoirs 4a, 4b are in fluid communication with cylindrical receptacles of fluid fluid (gas or liquid) operated by pressure 6, through sets of ducts 8. Preferably, the fluid is a gas. An upper and lower duct 8a, 8b, respectively, (see Figures 2 and 3) of the duct assembly 8, extend from the cylindrical receptacle 6, and are introduced into a respective reservoir 4a, 4b of the applicator assembly 2 to supply pressurized fluid to it. Each cylindrical receptacle 6 is mounted so that it can be released into a respective mounting member or track 91 that is part of or is fixed to the body part 12. Each cylindrical receptacle 6 includes a nozzle 124 (see Figure 3) having a valve 126 for controlling the flow of pressurized fluid contained therein to the reservoirs 4a, 4b by the duct assemblies 8. The release of the pressurized fluid, from the cylindrical receptacles 6, pushes the wound treatment material "W" through needles 24 during an operation of applying material for the treatment of surgical wounds.

To provide material for the treatment of wounds "W" from the reservoir 4a into the retention channel 14, as seen in Figures 6 and 7, the retention channel 14 preferably includes initially sealed openings 150 formed at along a base part 60 thereof for the passage of the material for the treatment of wounds "W" from the reservoir 4a mounted below the retaining channel 14. In use, according to a method of the present disclosure, after remove, break, penetrate or otherwise provide access or passage through a joint 61 (see Figure 6) covering the base part 60, the wound treatment material "W" flows from the reservoir 4a into the interior of the retention channel 14, through the openings 150 due to the

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pressure provided by the pressurized fluid of the cylindrical receptacles 6, and finally to and through the interior of the needles 24 before being dispensed with, on, above, below and / or between layers of tissue 120 (see Figure 9).

In a preferred embodiment, one of the tanks 4a, 4b stores a component of a wound treatment material "W" used in the formation of a two-part adhesive, for example, a glue, while the other of the deposits 4a, 4b stores a second component of the "W" wound treatment material used in the formation of the two-part adhesive, for example, an accelerator. In another preferred embodiment, as seen in Figure 6, a first compartment 156 of each reservoir 4a and / or 4b stores a component of a wound treatment material to form an adhesive while a second compartment of each reservoir 4a and / or 4b stores a second component of the wound treatment material used in the formation of the adhesive. Preferably, the first and second components are introduced into a common needle for application / delivery of the combined components to or in the treatment area.

Preferably, the tanks 4a, 4b are identical and contain an equal, complementary or adequate volumetric quantity of respective components of wound treatment material "W" to obtain and / or maintain a predetermined ratio of the first component with respect to the second component, relationship that can be

1: 1. In addition, preferably, the adhesive formed by the two components of the "W" wound treatment material is fibrin glue or fibrin sealant that acts as a hemostatic agent and as a tissue adhesive.

The fibrin sealant material is formed by rapid polymerization that occurs when a solution of proteomic coagulation factors, such as fibrinogen, comes into contact with a solution of a proteomic catalyst, such as thrombin. This rapid polymerization typically begins within two seconds after the solutions initially contact each other, and typically reaches partial hardening within ten seconds of contact. Due to the rapid polymerization after the intimate interaction of fibrinogen and thrombin, it is important to keep these two blood proteins separated until they are applied in the area of application. Therefore, it is preferred that the applicator set 2 supply each blood protein separately from the other blood protein using a different set of conduits for each protein and compartmentalizing surgical needles 24 to prevent mixing of the two components before that are applied to the application area.

It is contemplated that the material for the treatment of wounds "W" is any material for joining, healing, sealing or otherwise treating tissue. In a preferred embodiment, the wound treatment material is a biocompatible sealant material, including, and not limited to, sealants that harden after contact with the tissue, sealants that harden after exposure to ultraviolet (UV) light , sealants that are two-part systems that remain isolated from each other and are combined, or any combinations thereof. Any suitable known adhesive can be used. In one embodiment, said sealants and / or adhesives are curable. For example, sealant materials can be used that can have a cure time of about 10 to 15 seconds. In preferred embodiments, the sealant and / or adhesive material is a bioabsorbable and / or bioabsorbable material. In another embodiment, it is contemplated that a sealant and / or adhesive material having a curing time of approximately 30 seconds can be used. It is further provided that the "W" wound treatment material may be a previously hardened adhesive or sealant. The previously hardened adhesive or sealant material may react with moisture and / or heat of the body tissue to thereby activate the sealant and / or adhesive properties of the sealant or adhesive material.

In certain preferred embodiments, the wound treatment material comprises a sealing material. Said sealing material is desirably a PEG based material. Examples of classes of materials useful as sealant and / or adhesive material include acrylate or methacrylate functional hydrogels in the presence of a biocompatible photoinitiator, alkyl cyanoacrylates, isocyanate functional macromers with or without amine functional macromers, succinimidyl ester functional macromers with amine or sulfhydryl functional macromers, epoxy functional macromers with amine functional macromers, mixtures of proteins or polypeptides in the presence of aldehyde crosslinkers, Genipin, or water soluble carbodiimides, anionic polysaccharides in the presence of polyvalent cations, etc.

Some specific materials that can be used include isocyanate-terminated hydrophilic urethane prepolymers derived from organic polyisocyanates and oxyethylene-based diols or polyols, including those disclosed in U.S. Patent Nos. 6,702,731 and 6,296,607 and Patent Application United States published No. 2004/0068078; alpha-cyanoacrylate based adhesives including those described in US Patent No. 6,565,840; alkyl ester based cyanoacrylate adhesives including those disclosed in US Patent No. 6,620,846; biocompatible crosslinked polymer based base adhesives formed from water soluble precursors having electrophilic and nucleophilic groups capable of reacting and crosslinking in situ, including those disclosed in US Patent No. 6,566,406; two-part adhesive systems including those based on polyalkene oxide skeletons substituted with one or more isocyanate groups in combination with bioabsorbable diamine compounds, or polyalkylene oxide skeletons substituted with one

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or more amine groups in combination with bioabsorbable diisocyanate compounds as disclosed in published US Patent Application No. 2003/0032734; and isocyanate-terminated hydrophilic urethane prepolymers derived from aromatic diisocyanates and polyols as disclosed in published US Patent Application No. 2004/0115229.

It is provided and within the scope of the present disclosure that the "W" wound treatment material may include one or a combination of adhesives, hemostatic materials, sealants or any other material for the treatment of tissue or wounds. Materials for the treatment of "W" biocompatible surgical wounds, which may be used in accordance with the present disclosure, include adhesives whose function is to fix or hold organs, tissues or structures, sealing materials to prevent fluid leakage, and hemostatic materials to stop or prevent bleeding. Examples of adhesives that may be employed include aldehyde-based adhesive materials, protein derivatives, for example, commercially available albumin / glutaraldehyde materials marketed under the trade name BioGlue ™ by Cryolife, Inc., and materials based on cyanoacrylate marketed under the trade names Indermil ™ and Derma Bond ™ by Tyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively. Examples of sealants, which may be employed, include fibrin sealants and collagen-based fabric sealants and synthetic polymer-based sealants. Examples of commercially available sealants are synthetic polyethylene glycol-based hydrogel materials marketed under the trade name CoSeal ™ by Cohesion Technologies and Baxter International, Inc. Examples of hemostatic materials, which may be used, include topical hemostatic materials of fibrin, based on collagen, based on oxidized regenerated cellulose and based on gelatin. Examples of commercially available hemostatic materials are fibrinogen-thrombin combination materials marketed under the trade names CoStasis ™ by Tyco Healthcare Group, LP, and Tisseel ™ marketed by Baxter International, Inc. The hemostatic materials herein include astringent , for example, aluminum sulfate and coagulants.

The medicament may include one or more medical and / or surgically useful substances such as drugs, enzymes, growth factors, peptides, proteins, dyes, diagnostic agents or hemostasis agents, monoclonal antibodies, or any other pharmaceutical product used in prevention of stricture

The "W" wound treatment material may include viscoelastic film forming materials, crosslinking reagents and energy curable adhesives. It is envisioned that the material for the treatment of wounds "W", and in particular, the adhesive can harden when water and / or glycerin are applied. In this way, water and / or glycerin harden the adhesive and hydrate the wound.

It is envisioned that the wound treatment material "W" can be a relatively low viscosity fluid or liquid, so that the wound treatment material "W" can flow freely through the conduits 8 and / or needles 24. It is further provided that the wound treatment material "W" may include a fine powder of particulate material.

It is further contemplated that the "W" wound treatment material may include, for example, compositions and / or compounds that beneficially accelerate or modify the healing process when particles of the composition and / or compound are applied to or exposed. to a surgical repair area. For example, the material for the treatment of wounds "W" may be a therapeutic agent that will be deposited in the repair zone. The therapeutic agent can be selected for its antimicrobial properties, ability to promote repair or reconstruction and / or growth of new tissue. Antimicrobial agents such as broad-spectrum antibiotics (gentamicin sulfate, erythromycin or derived glycopeptides) that are slowly released to the tissue can be applied in this way to help fight clinical and subclinical infections in a tissue repair area. To promote tissue repair and / or growth, the "W" wound treatment material may include one or more factors that promote growth, for example, fibroblast growth factor, bone growth factor, epidermal growth factor , platelet derived growth factor, macrophage derived growth factor, alveolar derived growth factor, monocyte derived growth factor, magainin, and so on. Some therapeutic indicators are: glycerol with tissue or renal plasminogen activator to cause thrombosis, superoxide dimutase to clean free radicals that damage the tissue, tumor necrosis factor for oncological therapy or colony and interferon stimulating factor, interleukin-2 or other lymphokine for improve the immune system

The cartridge 22 is preferably manufactured from a polymeric liquid crystal material, although other materials are contemplated. The cartridge 22 has an edge 23 that engages with the retention channel 14 to fix, stabilize and, for example, prevent rotation into the cartridge 22.

As seen in Figures 3 and 4, for simplicity and ease of handling and assembly, the sliding drive platform 28 is preferably formed monolithically from a single piece of sheet that folds to the desired structural configuration. In this configuration, the sliding drive platform 28 defines a base portion 30, two upright wedge cams 32 and 34, and an upright rod 35 supporting a blade 36. Blade blade 36 is preferably punctually welded to the stem 35, although other known fixing methods may be used.

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The wedge cams 32 and 34 are axially staggered relative to each other so that one leads to the other through the translation of the sliding platform through the cartridge 22. In doing so, the driving forces within the cartridge 22 remain balanced during a surgical impulse operation. The longitudinal grooves 22a and 22b admit the longitudinal translation of the wedge cams 32 and 34, while the groove 22c admits the longitudinal translation of the stem 35.

The base part of the sliding drive platform 28 has a transverse groove 40, defined herein, which is dimensioned and configured to remove so that an upwardly oriented flange 42 formed at the distal end of a channel is released. elongated drive 44 (see figure 4). When the disposable loading unit 20 is placed in the retaining channel 14 and the sliding drive platform 28 is disposed in its most proximal position, the flange 42 is coupled so that it can be released with the slot 40. Therefore, the movement of the drive channel 44 moves the sliding drive platform 28 which, in turn, engages the pushers 26 to deploy the needles 24. After an adhesive application operation, the disposable loading unit 20 can be removed from the channel of retention by easily decoupling flange 42 from groove 40.

Continuing with the reference to Figure 4, the drive channel 44 is defined by a base portion 45 and two parallel raised bars 46 and 48 of elongated configuration. The distal ends of the bars 46 and 48 are staggered to coincide with the staggered orientation of the wedge cams 32 and 34, respectively. The proximal end of each bar 46, 48 is projected backward to engage a mounting block 49 that is associated with an activation command 50. A pair of slots 52 (of which only one is shown) are formed in the block assembly 49 to receive the proximal end of each of the upright bars 46, 48 of the drive channel 44. The slots 52 are provided with stops 54 to engage the openings 56 at the ends of the retaining bar so that they can the bars 46, 48 are locked in the mounting block 49. In use, the longitudinal movement of the activation command 50 causes the corresponding longitudinal translation of the drive channel 44 and the drive of the sliding platform 28.

With reference to Figures 3 and 6, the retaining channel 14 includes a base portion 60 and two upright parallel walls 62 and 64. Numeric indexes are printed on the walls 62, 64 of the retaining channel 14 to indicate the length of the adhesive line Retention structures are provided at the distal end of each of the walls 62, 64 to engage corresponding structures provided in the disposable loading unit 20. In particular, notches 66a and 66b are provided for coupling to corresponding protrusions, such as the extrusion 67, and grooves 68a and 68b are provided to engage corresponding stops, such as the stop

69. These structures inhibit the lateral, longitudinal and perpendicular displacement of the cartridge 22 (and the disposable loading unit 20) within the retention channel 14. Ramp coupling slots 70a and 70b are also defined on the opposite walls of the retention channel 14 to interact with a pair of opposite protrusions 72a and 72b (see Figures 3 and 4) to guide the disposable loading unit 20 into the retention channel 14 when it is loaded in the surgical apparatus 10.

Continuing with the reference to Figure 3, the surgical apparatus 10 further includes an elongated anvil support bar 80 which has a generally U-shaped cross-sectional configuration. The proximal end portion 82 of the support bar 80 has a notched area 84 to engage a pair of corresponding stops 86 (only one shown) extending into the cavity 15 of the body part 12 adjacent to the proximal end thereof. The stops 86 are coupled when the cartridge or first half-section 11a and the anvil or second half-section 11b are paired with each other. The distal end portion 88 of the anvil support bar 80 is configured to support a preformed plate 90 having a plurality of openings 141 (see Figure 9) in alignment juxtaposed with a respective needle 24 to receive a part of the needle 24 inside during the surgical procedure.

The plate 90 is preferably formed from a unitary piece of metal and cold formed and stamped to define the plurality of needle receiving openings 141 (see Figure 5). Each needle receiving opening 141 is in alignment with a particular needle 24 housed within the cartridge 22. The plate 90, as shown in Figure 3, is provided with two opposite pins 92a and 92b extending inwardly to engage with complementary coupling slots 93b (only one shown) on the anvil support bar 80 during manufacturing and assembly. The cross-sectional configuration of the plate 90 is sized to complement the cross-sectional geometry of the support bar 80 (see Figure 5). More particularly, the cavity 93 extending along the plate length 90 corresponds to a similar channel formed in the support bar 80. These areas house the rod 35 and the blade blade 36 as it travels distally to form an incision in the body tissue, an incision that is collided by the adhesives during a surgical adhesive application operation.

A pair of rectangular openings 95a and 95b are formed in the plate 90 adjacent to the proximal end thereof to receive a pair of correspondingly positioned flanges or projections 96a and 96b projecting upwardly away from the contact surface with the fabric 97 (see Figures 3 and 4). The interaction between

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openings 95a, 95b and flanges 96a, 96b ensures that the cartridge 22 and plate 90 are properly aligned with each other during a surgical adhesive application procedure.

A lower surface 160 of the upper tank 4b is preferably manufactured from an elastomeric or other suitable material 161. The lower surface 160 is fixed to the anvil support bar 80. During a surgical adhesive application procedure, the needles 24 penetrate in the elastomeric material 161 of the reservoir 4b and the pressurized adhesive flows into the needles 24 (see Figure 9). It is envisioned that the elastomeric material 161 may include a series of weakened lines formed inside and level with the needles 24. Thus, a reduced force is required for the needles 24 to penetrate the elastomeric material 161.

After the needles 24 dispense the wound treatment material "W", the needles 24 retract into the disposable loading unit 20 and the elastomeric material 161 reseals the reservoir 4b to release the tissue 120, 122 of the needles 24 and to prevent the spilling of the remaining adhesive contained in the reservoir 4b. In one embodiment, the needles 24 can exit the reservoir 4b as the surgeon increases the pressure from the reservoir 4b to push the needles 24 back into the disposable loading unit 20. In another embodiment, a spring 98 (see Figure 7) may be properly disposed and / or properly positioned around each needle 24 to return the needles 24 to the unfolded state after retraction of the sliding drive platform 28. In particular, in use, when the feed is advanced sliding drive platform 28 to move the pushers 26, the springs 98 are compressed and held compressed by the bars 46, 48 of the drive channel 44 that remain in contact with the pushers

26. When the sliding drive platform 28 is removed proximally, after the application of wound treatment material "W", the springs 98 expand and thereby move or retract the needles 24 back inside the unit Disposable load 20.

With reference to Figures 1-3, the anvil or the second half section 11b of the apparatus 10 further includes the clamping handle 100 which is used to firmly hold tissue between the surface of the plate 90 and the surface of contact with the fabric 97 of the cartridge 22. The clamping handle 100 is mounted so that it can pivot on the anvil support bar 80 around a transverse pivot pin (not shown). A pair of retaining hooks 102a and 102b hang from the clamping handle 100 to interact with the U-shaped clamping bar 104 supported within the internal cavity defined in the body part 12.

When the apparatus 10 is mounted before use, the notched area 84 at the proximal end 82 of the anvil support bar 80 is coupled with the cooperative stops 86 in the internal cavity 15 of the body part 12. Next, the anvil or second half-section 11b is matched with the cartridge or first half-section 11a, and the clamping handle 100 is disposed in the upright non-held position shown in Figure 1. Subsequently, when the body tissue is properly disposed between the surface of the plate 90 and the tissue contact surface 97 of the cartridge 22, the anvil or second half section 11b is pivoted towards the cartridge or first half section 11a, around the stops in the body part 12, so that the distal ends of the clamping hooks 102a and 102b are located immediately adjacent to the proximal end of the base of the U-shaped clamp bar 104. Concomitantly, the flanges 96a and 96b are coupled to the the openings 95a and 95b in the plate 90 to ensure proper alignment of the anvil and the cartridge.

Next, to firmly hold the captured body tissue, the clamping handle 100 is pivoted from the position illustrated in Figure 1 to that shown in Figure 2. At that time, the clamping hooks 102a and 102b are coupled with the base of the clamping bar 104, blocking the apparatus 10 in a subject state. During clamping, the captured body tissue exerts a counter-force against the contact surface with the tissue 97 of the cartridge 22 and the surface that forms the plate fixator 90, pushing the two structures to separate. To overcome these forces and prevent the proximal part 82 of the anvil support bar 80 from bending, bearing surfaces are defined within the retaining channel 14 to withstand the compression forces generated during clamping. In particular, as illustrated in Figure 3, opposite bearing shelves 110a and 110b are formed by stamping on opposite walls 62 and 64 of the retaining channel 14. The supporting shelves 110a, 110b are positioned to meet the middle section of the Anvil support bar 80 near the pivot point of the clamping handle. It is desirable to provide a locking mechanism to prevent the device from operating again after it has been operated.

Referring now to Figures 7-9, a method of applying a material for the treatment of surgical wounds "W", in this case an adhesive, is illustrated. According to the procedure, a plurality of needles 24 are deployed or pushed from the cartridge 22, by sliding drive platform 28 or by the wedge cams or surfaces 32a, 34a (see Figure 4), through holes needle outlet 122 and are driven into the fabric 120 before, during or after being received by the needle receiving openings 141 of the plate 90. Meanwhile, the blade blade 36 (see Figure 4) cuts through the fabric 120 forming a cutting line of the blade along the groove 22c. In operation, before activating the surgical apparatus 10, the sliding drive platform 28 is in the most proximal position. At that time, the blade 36 is enclosed in the protective housing 25 (see Figures 3 and 4) formed adjacent to the proximal end of the disposable loading unit 20.

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To activate the surgical apparatus 10, after the tissue 120 has been held between the distal ends of the first and second half sections, the activation command 50 moves in a distal direction. Accordingly, as illustrated in Figure 8, by moving the activation knob 50 in a distal direction, the drive channel 44 drives the sliding drive platform 28 distally into and through the cartridge 22. During its distal translation , the angled front surfaces of the wedge cams 32 and 34 sequentially contact the pushers 26, pushing them in a direction transverse to the direction of movement of the sliding drive platform 28. As a result, the pushers 26 push the needles 24 from their individual outlet holes 122, propelling needles 24 into tissue 120 before being received by corresponding needle receiving openings 141 provided in plate 90 (see Figure 9).

The sequential activation of the needles 24 continues until the sliding drive platform 28 is advanced to the most distal end of the cartridge 22, at which time all the needles 24, once housed inside the cartridge 22, have been pushed outside the disposable loading unit 20 and a cutting line of the blade in the fabric 120 has been formed by the blade 36. To the cutting line of the blade and outer, inner and / or interstitial regions of the fabric 120 , as desired, adhesive is supplied by opening the valve 126 and allowing the pressurized fluid contained in each cylindrical receptacle 6 to be released into the tanks 4a, 4b to thereby push the wound treatment material "W" , shown in this case for example as the adhesive "A", or each component of the adhesive "A1, A2", in the region or regions between the fabric 120, through the needles 24 and through the holes 121 as well as to the cutting line of the blade through the groove 22c. The valve 126 is kept open until sufficient adhesive "A" is dispensed, all adhesive "A" is dispensed, and / or all the pressure inside the cylindrical receptacle 6 is exhausted.

Next, the activation command 50 retracts to its original position, causing the needles 24 to retract into the disposable loading unit 20, for example, by means of a compression spring or other solicitation means 98 disposed between the Needle pushers 26 and an internal surface of the contact surface with the fabric 97 of the disposable loading unit 20, the first and second half sections are separated, and the disposable loading unit 20, as well as one or both reservoirs 4a, 4b , can be removed from the retaining channel 14. Preferably, solicitation means 98 are disposed around each needle 24 of each pusher 26. Subsequently, a new, fully loaded disposable loading unit 20 can be placed in the retaining channel 14 so that the slot 40 of the sliding drive platform 28 is coupled with the flange 42 of the drive channel 44 to allow reuse of the apparatus 10.

It is provided that cylindrical receptacles 6 can also be replaced as necessary. Alternatively, it is provided that the reservoirs 4a, 4b can be fluidly coupled to a remote pressure source (not shown), thereby obviating the need for cylindrical receptacles 6. In yet another embodiment, it is provided that the reservoirs 4a , 4b can be fluidly coupled to a hand-operated pressure source, for example, a syringe, hand pump, etc.

Although the present apparatus has been described with respect to preferred embodiments, it will be readily apparent to those skilled in the art to which it belongs that changes and modifications can be made therein without departing from the scope of the present apparatus. For example, the invention can be applied to an endoscopic as well as an open-type surgical apparatus, for example, of anastomosis. The invention can be easily applied to hand-operated or remotely operated linear endoscopic staplers, for example, robotically using, for example, a pair of jaws, for example, an anvil and a cartridge, to sequentially or simultaneously apply a material for treating wounds to a tissue treatment area.

It is further provided that the tanks 4a, 4b can be pressurized when the handle or handles 100 of the apparatus 10 are actuated to close and / or otherwise hold the apparatus 10 on the fabric 120. For example, the handle or handles 100 of the apparatus 10 they can act as manual pumps to push additional fluid (eg gas or liquid) into the tanks 4a, 4b thereby increasing the pressure inside the tanks 4a, 4b. Therefore, when the needles 24 penetrate the joints 61, 161, the wound treatment material "W" is pushed out of the reservoirs 4a, 4b.

Turning now to Fig. 10, in an alternative embodiment, the surgical apparatus 10 includes a cam device 150, which includes a cam roller 152, arranged so that it can move in translation within the body part 12. In operation, After the distal ends of the first and second semi-sections 11a, 11b of the surgical apparatus 10 have been attached to the tissue 120, the cam device 150 is advanced distally through the body part 12 and the disposable loading unit 20 for unfolding the needles 24. Desirably, six (6) rows of needles 24 may be provided that extend substantially the entire length of the distal ends of the first and second half sections 11a, 11b. Once the needles 24 have been deployed, the wound treatment material "W", in the form of a tail and an accelerator can be driven or fed through the respective distal ends of the first and second half sections 11a, 11b and inside the needles 24 where the two components are mixed when they leave the perforations formed in the needles 24 to join or seal the tissue. Finally, a blade can be provided (not shown)

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to dissect the tissue in two halves along the center of the distal ends of the first and second half sections 11a, 11b. The flow of pressurized fluid and / or wound treatment material "W" can be activated by signals from one or more sensors located and activated properly. Turning now to Figure 10, an alternative embodiment of the surgical apparatus 10 is shown and described.

5 surgical apparatus 10 may include a first fluid supply channel 162 extending through the distal end of the first half section 11a, and a second fluid supply channel 164 extending through a distal end of the second half section 11b Desirably, the first fluid supply channel 162 is in fluid communication with at least some, preferably, each staple receiving / forming pocket 166 formed on a contact surface with the tissue of the distal end of the first half section 11a.

Additionally, the second fluid supply channel 164 is in fluid communication with at least some, preferably each staple retaining slot 168 provided on a contact surface with the tissue of the distal end of the second half section 11b. A surgical clip 170 is desirably disposed in each clip retention slot 168. As is conventional, each clip retention slot 168 is in alignment juxtaposed with each clip receiving / forming pocket 166.

Each channel 162, 164 is fluidly connected to the same or to individual fluid sources (not shown), for example as described above. In this manner, the fluid in the form of wound treatment material "W" can be supplied to staple retention slots 168 and / or staple receiving / forming pockets 166 via respective channels 162, 164.

20 Accordingly, in use, after activating the surgical apparatus 10, the staples 170 are deployed from the staple retention slots 168 to penetrate through the tissue and to be formed within the staple receiving / forming pockets 166. concomitant with this, the wound treatment material "W" is dispensed from the staple retention slots 168 and / or the staple receiving / forming pockets 166,

25 as described above.

It will be understood that various modifications can be made to the embodiments of the surgical apparatus disclosed herein. Therefore, the above description should not be construed as limiting, but simply as exemplifications of embodiments. Those skilled in the art will devise other modifications

30 within the scope of the present claims.

Claims (14)

5 fifteen 25 35 Four. Five 55 65 1. A surgical apparatus (10), comprising: a first half section (11a) adapted to receive a disposable loading unit (20) at a distal end thereof; a second half section (11b) in juxtaposed relationship with the first half section; a disposable loading unit (20) selectively operatively coupled with the distal end of the first half section, including the disposable loading unit: a cartridge (22); a plurality of deployable needles (24) supported within the cartridge, in which each needle includes a light extending therethrough and at least one hole (121) formed in an outer periphery thereof; a needle pusher (26) in operative association with each needle to deploy each needle from the cartridge and into a target tissue; and an actuating member (28) arranged so that it can travel in translation within the cartridge to supply a driving force to each needle pusher to deploy the needles from the cartridge; Y a set of material applicator for the treatment of wounds to supply material for the treatment of wounds to the target surgical area, including the applicator assembly: a first (4a) and a second (4b) reservoir resting on the distal end of a respective first and second semi-section; and a source of material for the treatment of wounds (6) in fluid communication with each deposit.

2.

The surgical apparatus according to claim 1, wherein the source of material for the treatment of wounds is at least one pressurized cylindrical receptacle of material for the treatment of wounds.

3.

The surgical apparatus according to claim 2, wherein each cylindrical receptacle is supported on one of the first and second half sections.

Four.

The surgical apparatus according to claim 3, wherein each needle pusher includes an opening formed therein for fluid communication with the light of the respective needle.

5.

The surgical apparatus according to claim 4, wherein the distal end of the first half section includes a plurality of openings provided between the reservoir and the cartridge resting thereon, to allow the transmission of material for the treatment of wounds from the reservoir. to the cartridge

6.

The surgical apparatus according to claim 5, wherein a plate that includes a plurality of needle receiving openings is supported on the distal end of the second half section.

7.

The surgical apparatus according to claim 6, wherein a distal end of each needle enters a respective needle receiving opening of the second semi-section during operation of the surgical apparatus.

8.

The surgical apparatus according to claim 7, wherein an elastomeric material confines the material for the treatment of wounds within the reservoir supported on the distal end of the second semi-section.

9.

The surgical apparatus according to claim 8, wherein, at the time of operation of the surgical apparatus, a distal end of each needle penetrates the elastomeric material and the light of each needle is in fluid communication with the reservoir resting on the distal end of the second half section.

10.

The surgical apparatus according to claim 9, wherein the wound treatment material is at least one of an adhesive, a sealing material, a hemostatic material and a medicament.

eleven.

The surgical apparatus according to claim 10, wherein the disposable loading unit includes a requesting member operatively associated with at least one of the needles to request the needles to a retracted state.

12.

The surgical apparatus according to claim 11, further comprising a knife blade resting on the drive member to cut the tissue held between the distal ends of the first and second half sections, in which the blade blade travels at along a longitudinal groove provided in the cartridge.

13.

The surgical apparatus according to claim 12, wherein at least some needles are disposed on both sides of the longitudinal groove of the cartridge.

14.

The surgical apparatus according to claim 1, wherein the applicator assembly includes a valve interposed fluidly between the source of wound treatment material and the reservoir.

12